Effects on Healthcare and Research
a) Effects on Healthcare
The complexities of HIPAA accompanied with potentially stiff penalties for violators, can lead healthcare organizations and physicians to withhold relevant information from those individuals who may have a right to it or are associated with it. A recent review of the implementation of the HIPAA Privacy Rule by the U.S. Government Accountability Office found that healthcare providers were uncertain about their responsibilities pertaining to privacy, confidentiality and legal matters. Such healthcare service providers responded with an over-guarded approach quite frequently, especially when it came to disclosure of relevant data or information and thereby were unable to ensure compliance with the Privacy rule under HIPAA as desired. Till date the reports of this uncertainty continues to prevail.
b) Effects on Research
On account of restrictions imposed by HIPAA on the researchers, it has resulted in their inability to perform retrospective, chart-based qualitative and quantitative research of databases and their ability to prospectively evaluate patients by contacting them for a follow-up. Both – Clinical Research and Market Research activities are bought under purview of HIPAA. A survey project from the University of Michigan demonstrated that by implementing HIPAA Privacy rule, there was a significant drop from 96% to 34% pertaining to follow-up surveys completed by study patients being subsequent to a Myocardial infarction (heart attack). In another study, showcasing the effects of HIPAA on patient recruitment process for a cancer prevention study, the results depicted that HIPAA-mandated changes led to a 73% decrease in patient accrual accompanied with tripling of time spent on recruitment of patients with tripling of mean recruitment costs.
Under HIPAA, it is mandatory to include informed consent forms meant for research studies that are required to incorporate extensive details as to how the participant's protected health data and information would be kept with confidentiality. It is important to note that even though such information is essential , the addition of a lengthy, legal section regarding confidentiality and privacy may make such complex documentation a cumbersome and less user-friendly process especially for patients who are required to read, grasp, understand and sign on the streamlined or standardized processes.
Based on the feedback received pertaining to privacy rule in the manner and method in which the HIPAA process is being currently implemented, this is definitely going to have negative impact on the cost and quality of medical research studies. Dr. Kim Eagle, professor of internal medicine at the University of Michigan, was quoted in the Annals article as saying, "Privacy is important, but research is also important for improving care. We hope that we will figure this out and do it right.”
Special considerations for data privacy and confidentiality are required for healthcare organizations offering federally-funded drug or alcohol rehabilitation products and services. Prior to the enactment of this act, other legislation acts that preceeded HIPAA by over a quarter century include Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1970 and language amended by the Drug Abuse Office and Treatment Act of 1972.
It is important to note that Privacy Rule of HIPAA does not override the FDA’s Human Subject Protection Regulations.